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Monoclonal Antibodies

Belimumab for Low Lymphocyte Count

Phase 1
Recruiting
Led By Irini Sereti, M.D.
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Aged 18-70 years
Female participants of childbearing potential must agree to use adequate contraception when engaging in sexual activities that can result in pregnancy, beginning at day 0 (or day 30 for hormonal contraception) until 4 months after the last dose of belimumab
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 2 through week 48
Awards & highlights

Study Summary

This trial is testing whether the drug belimumab is safe for people with Idiopathic CD4 lymphopenia, a condition which lowers the number of white blood cells that fight against infection.

Who is the study for?
Adults aged 18-70 with Idiopathic CD4 Lymphopenia (ICL), enrolled in NIH study 09-I-0102, and have low CD4 counts plus autoantibodies. They must use effective contraception and not be pregnant or breastfeeding. Exclusions include prior belimumab use, HIV, severe illnesses, certain infections, liver/kidney issues, recent vaccines, steroid use (except nasal/inhaler), cancer treatments within 6 months.Check my eligibility
What is being tested?
The trial is testing the safety of a drug called belimumab for people with ICL. Participants will receive eight doses via IV over several weeks and undergo monitoring through physical exams as well as blood and urine tests during treatment and follow-up visits.See study design
What are the potential side effects?
Potential side effects of belimumab may include allergic reactions to its components; however specific side effects are not listed here but will be monitored through physical exams and various tests throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 70 years old.
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I agree to use birth control from the start of the study until 4 months after my last dose.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~all study visits
This trial's timeline: 3 weeks for screening, Varies for treatment, and all study visits for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of adverse events (AEs) that are possibly, probably, or definitely related to belimumab.
Secondary outcome measures
Evaluation of CD4 and CD8 counts at all study visits.
Evaluation of any known clinical autoimmune disease (eg, hemolytic anemia) or positive autoantibodies such as ANA at all study time points.
Evaluation of natural killer (NK) and B-cell counts at all study visits.
+1 more

Side effects data

From 2018 Phase 3 trial • 80 Patients • NCT02119156
36%
Nasopharyngitis
18%
Hypokalaemia
9%
Gastroenteritis
9%
Cystitis
9%
Joint injury
9%
Vertigo
9%
Ocular discomfort
9%
Periodontal disease
9%
Lumbar vertebral fracture
9%
Upper respiratory tract infection
9%
Dental caries
9%
Musculoskeletal chest pain
9%
Cough
9%
Otitis externa bacterial
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment Phase: Treatment Holiday Group - Re-start Phase
Maintenance Phase: Treatment Holiday
Treatment Phase: Long-term Discontinuation Group
Treatment Phase: Treatment Control Group
Treatment Phase: Treatment Holiday Group - Holiday Phase
Maintenance Phase: Treatment Control

Trial Design

1Treatment groups
Experimental Treatment
Group I: Single arm, open-labelExperimental Treatment1 Intervention
Belimumab 10 mg/kg once every 2 weeks for 3 doses, and then once every 4 weeks for 5 doses, delivered via 1-hour intravenous (IV) infusion.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Belimumab
2013
Completed Phase 4
~1840

Find a Location

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,270 Previous Clinical Trials
5,485,217 Total Patients Enrolled
1 Trials studying Idiopathic CD4 Lymphopenia
60 Patients Enrolled for Idiopathic CD4 Lymphopenia
Irini Sereti, M.D.Principal InvestigatorNational Institute of Allergy and Infectious Diseases (NIAID)
8 Previous Clinical Trials
2,627 Total Patients Enrolled

Media Library

Belimumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04097561 — Phase 1
Idiopathic CD4 Lymphopenia Research Study Groups: Single arm, open-label
Idiopathic CD4 Lymphopenia Clinical Trial 2023: Belimumab Highlights & Side Effects. Trial Name: NCT04097561 — Phase 1
Belimumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04097561 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what demographic is this research initiative open?

"This trial is searching for 20 qualified participants, aged between 18 and 70 years of age, who have CD4 antigens. More specifically, these candidates need to have a CD4 count lower than 300 cells/microliter in at least 2 separate measurements taken 6 weeks apart any time within the past 90 days. Furthermore, evidence suggesting autoantibody positivity must be present (e.g., ANA or research flow method detecting antilymphocyte antibodies). Those capable of bearing children are mandated to use reliable contraception during sexual activities that could lead to pregnancy from day 0 (or day 30 if hormonal contraception is employed) until 4"

Answered by AI

Has Belimubab been granted regulatory clearance by the FDA?

"Belimubab's safety was rated as 1 due to its Phase 1 trial status, which implies that there is only a minimal amount of clinical data regarding efficacy and security."

Answered by AI

How many participants are eligible for this research trial?

"Indeed, records available on clinicaltrials.gov demonstrate that this research is actively recruiting participants. It was initially posted on January 13th 2020 and its latest update was made October 28th 2022; the study requires 20 individuals to enrol at a single site."

Answered by AI

Are there still openings for participants in this clinical research?

"Per the information found on clinicaltrials.gov, recruitment for this research endeavour is ongoing and was launched on January 13th 2020. The trial has since been updated as of October 28th 2022."

Answered by AI

Is age greater than 55 years an exclusion criterion for this research endeavor?

"This medical investigation is open to citizens aged 18 or older and under 70."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Safety of Belimumab in People With Idiopathic CD4 Lymphopenia and Autoantibodies (Phoebe)
2020. "Safety of Belimumab in People With Idiopathic CD4 Lymphopenia and Autoantibodies (Phoebe)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04097561.
~3 spots leftby Dec 2024
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